Sterilization traceability is not just record-keeping — it's a legal obligation with precise requirements. SecuSteri is designed to meet them.
In the Netherlands, clear requirements govern the reprocessing of medical devices across all professions that use reusable instruments. Dental practices operate under the Wkkgz (Care quality, complaints and disputes act) Articles 2 and 3 and the Wmh (Medical devices act, BWBR0042755) -- the national implementation of EU Regulation 2017/745 (MDR) via the Besluit medische hulpmiddelen (BWBR0043470, Stb. 2020, 130). The KNMT guideline on infection prevention in dental practices is the operational field standard; the IGJ Supervision Framework for Infection Prevention in Dental Care (2018), supplemented by the IGJ infection-prevention attention points with KNMT (January 2026), is the basis for unannounced supervision. Tattooing, piercing, and permanent makeup fall under the Warenwetbesluit on tattooing and piercing (BWBR0021605) with a three-year GGD permit and NEN-EN 17169:2020 as the designated safety code (Stcrt. 2022, 4132, since 1 May 2022). Podiatrists are protected Wet BIG Article 34 healthcare professionals operating under the NVvP practice guideline on hygiene and infection prevention 2021 and -- since 26 January 2026 -- the IGJ Supervision Framework for Paramedical Care, which assesses five themes: person-centered care, collaboration, quality policy, personnel policy and recordkeeping. NEN-EN 13060 defines the technical requirements for small steam sterilizers (class B, S, and N). SecuSteri covers the documentation obligations of every regulated profession in the Netherlands.
The Wkkgz and the KNMT guideline on infection prevention require complete batch documentation for each sterilization cycle, demonstrating that parameters have been met. During an IGJ practice visit, the quality of this documentation is reviewed. SecuSteri generates a traceability record for each batch, digitally released by the operator with their personal PIN code. Once released, the record is locked -- no modifications are possible. It is the digital equivalent of a dedicated sterilization register, without the risks of fading thermal printouts or illegible handwriting.
The KNMT guideline on infection prevention and the NVvP practice guideline on hygiene and infection prevention 2021 require seamless traceability from the autoclave to the patient. SecuSteri goes further: every sterilized instrument is linked to its batch, operator, container, and use-by date. The traceability chain is complete and verifiable -- from the sterilization cycle to the patient record.
Every significant action in SecuSteri is recorded in a tamper-evident audit trail: who did what, when, and on which record. This trail is append-only -- technically impossible to modify or delete, even by an administrator. In the event of an IGJ practice visit, or a disciplinary proceeding before the regional disciplinary tribunals, the complete history of operations is available.
Each operator releases batches with their personal 4-digit PIN code. This release individually identifies the person responsible for validating the batch -- essential for personal accountability under the Wkkgz. The PIN is stored as a cryptographic hash (bcrypt) -- even the SecuSteri administrator cannot read it.
The KNMT guideline on infection prevention and NEN-EN 13060 require three levels of control: physical (cycle parameters), chemical (indicators), and biological (spore tests). SecuSteri tracks all autoclave checks -- vacuum test, Bowie-Dick, helix, biological controls -- linked to each device, with date and result. During an IGJ practice visit, the complete check history for each autoclave is available instantly.
For patient-record-linked sterilization data the 20-year WGBO retention applies (BW Article 7:454, in force since 1 January 2020) -- the longest retention period for sterilization documentation in any European market where SecuSteri operates, four times longer than the German MPBetreibV requirement of 5 years. SecuSteri automatically retains your data according to your plan duration: 5 years (Standard), 10 years (Pro), unlimited (Clinic+). No risk of loss, fire, or water damage. Your sterilization documentation is always accessible -- whether for an IGJ practice visit, a disciplinary proceeding, or your own quality assurance.
Your data is hosted in the European Union on the Scaleway infrastructure in Paris. The Netherlands, as an EU member state, is fully covered by the GDPR. EU hosting meets all data residency requirements. The transfer between your browser and our servers is encrypted (TLS). Data at rest is encrypted. SecuSteri is GDPR compliant: right of access, right to data portability, right to erasure. Your data never leaves the EU. We never sell your data and never use it for advertising.
You can request a complete export of all your data (batches, instruments, autoclaves, audit trail) as a zipped CSV archive, delivered by email. The export covers your plan's retention window. Your data belongs to you -- you can retrieve it at any time.
The paper register remains the standard in many Dutch practices. But paper records present documented risks: missing pages, illegible handwriting, forgotten entries after a rushed cycle, inability to search quickly, and no backup in case of disaster. Thermal printouts from autoclaves fade over time. With a single national supervisor in the IGJ, a 20-year WGBO retention for patient-record-linked sterilizations, and the additional IGJ infection-prevention attention points with KNMT (January 2026) -- plus enforcement instruments such as an aanwijzing (formal direction) or last onder dwangsom (cease-and-desist with penalty) under Wkkgz Article 11 -- having digital records instantly accessible is a decisive advantage. Application of the harmonized NEN-EN standards provides the basis for demonstrating the state of the art during inspection -- SecuSteri makes that demonstrable. SecuSteri eliminates the risks of paper records while meeting the same professional obligations.
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